Patient-reported outcomes in a survey of patients treated with oral antihyperglycaemic medications: Associations with hypoglycaemia and weight gain.

Aim To examine the association between medication side-effects (SEs) and patient-reported outcomes (PROs) among patients with type 2 diabetes treated with oral antihyperglycaemic agents (OAHAs). Methods A total of 1984 participants responded to an internet-based survey in the United States. Data were collected on hypoglycaemia 6 months and weight gain 12 months prior to the survey. Health-related quality of life (HRQoL) was measured using the EuroQol-5D (EQ-5D). Also administered were the Treatment Satisfaction Questionnaire for Medication v.1.4 (TSQM) and the Hypoglycaemia Fear Survey II (HFS). Results Symptoms of hypoglycaemia were reported by 62.9% of participants, and 36.9% reported weight gain. For those reporting hypoglycaemia, mean scores were lower for TSQM and EQ-5D and higher for HFS when compared with those with no symptoms (TSQM: 69.7 vs. 75.1; EQ-5D: 0.78 vs. 0.86; HFS: 17.5 vs. 6.2; all p < 0.0001). The same remained true when accounting for symptom severity, where severity was monotonically related with PRO scores (all p < 0.0001). Similarly, reported weight gain was associated with lower treatment satisfaction (69.0 vs. 73.3) and HRQoL (0.77 vs. 0.83), and increased fear of hypoglycaemia (15.7 vs. 11.8) (all p < 0.0001). In mixed linear regression analysis, the associations between medication SEs and PROs remained significant after adjusting for patient and disease characteristics. Conclusions Among patients with type 2 diabetes treated with OAHAs, self-reported hypoglycaemia and weight gain were associated with decreased treatment satisfaction and HRQoL. In addition, the presence of these SEs was associated with increased fear of hypoglycaemia.